Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
An International, Phase 2, Open-Label, Efficacy and Safety Study of MDV9300 in Patients With an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B-Cell Lymphoma
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy. Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.
Trial Health
Trial Health Score
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Started Dec 2016
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedNovember 25, 2016
November 1, 2016
1.5 years
January 11, 2016
November 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Best overall response rate
Defined as the proportion of patients in the intent-to-treat population with a complete response (CR) or partial response (PR) attributable to study treatment, as assessed by the independent review committee (IRC).
no later than 6 months after the last patient is enrolled in a cohort
Secondary Outcomes (5)
Duration of response (for responders)
no later than 6 months after the last patient is enrolled in a cohort
Progression-free survival
no later than 6 months after the last patient is enrolled in a cohort
Time to response (for responders)
no later than 6 months after the last patient is enrolled in a cohort
Overall survival
no later than 6 months after the last patient is enrolled in a cohort
Composite of safety
no later than 6 months after the last patient is enrolled in a cohort
Study Arms (1)
MDV9300
EXPERIMENTALInterventions
MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.
Eligibility Criteria
You may qualify if:
- Age 18 years or older and willing and able to provide informed consent;
- Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;
- Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;
- For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;
- For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT just prior to MDV9300 treatment must have resulted in a PR or stable disease;
- Adequate bone marrow reserve as defined per protocol;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Patients with stable ECOG scores of 2 may be allowed with medical monitor approval.
You may not qualify if:
- Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma
- History of serious autoimmune disease;
- History of central nervous system involvement of lymphoma;
- Prior therapy with agents targeting immune coinhibitory receptors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivation, Inc.lead
Study Sites (1)
Unknown Facility
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 13, 2016
Study Start
December 1, 2016
Primary Completion
June 1, 2018
Study Completion
August 1, 2018
Last Updated
November 25, 2016
Record last verified: 2016-11